Cambridge, Massachusetts 02142


Purpose:

The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease who receive alglucosidase alfa.


Criteria:

Inclusion Criteria: - Must be enrolled in Pompe Registry (NCT00231400) - Must be pregnant and intend to breast-feed or be currently lactating and receive at least one infusion of alglucosidase alfa while lactating - Provide a signed Patient Information and Authorization form to participate in the sub-registry prior to any sub-registry-related assessments are performed - Agree to adhere to the sub-registry guidelines for antibody testing and recommended schedule of assessments. Exclusion Criteria: - Patients will be excluded from this sub-registry if they have received an investigational drug (excluding alglucosidase alfa in regions where alglucosidase alfa is not commercially available) within 30 days prior to Visit 1 breast milk collection


NCT ID:

NCT00566878


Primary Contact:

Study Director
Medical Monitor
Genzyme, a Sanofi Company

Medical Information
Phone: 800-745-4447
Email: MedInfo@genzyme.com


Backup Contact:

Email: MedInfo@genzyme.com
Medical Information
Phone: 617-252-7832


Location Contact:

Cambridge, Massachusetts 02142
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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